Dietary Intervention With High Phenolic EVOO in CLL
NCT04215367 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2020-01-02
Summary
Daily intake of extra virgin olive oil (EVOO), which is the major component of the Mediterranean diet and also a source of monounsaturated fat, may be partly responsible for the increased life expectancy of the Mediterranean people. A high dietary intake of EVOO is correlated with lower incidence of cancer, cardiovascular disease, metabolic diseases, Alzheimer's disease and osteoporosis Oleocanthal, a phenolic derivative of extra virgin olive oil, has important health promoting anti-cancerous properties, since it can inhibit the growth and promote the apoptosis of several cancer cells.
The purpose of the present study was to investigate the effect of dietary intake of olive oil rich in oleocanthal on hematological, metabolical, cell progression markers and disease progression in patients with Chronic Lymphocytic Leukemia. The aim is also to study the possible association of apoptosis in the mechanism of action of virgin olive oil phenols in a patient with CLL in order to find the possible mechanism of the cellular action of oleocanthal in neoplasia.
After the screening of \>300 EVOO samples the investigators selected an EVOO with high oleocanthal and oleacin concentration of 416 and 284 mg/Kg respectively (EVOO OC/OL). Pilot dietary intervention was made in a group of 21 patients with chronic lymphocytic leukemia (CLL) who did not follow any treatment. EVOO was administered 40 ml/day for six months. Biochemical, hematological and molecular markers were studied six month before the intervention and six month during the intervention
Conditions
- Chronic Lymphocytic Leukemia (CLL)
Interventions
- DIETARY_SUPPLEMENT
-
High phenolic EVOO intake
During the pilot dietary intervention patients with CLL consumed before their meals, 40 ml/day high phenolic EVOO for 6 months
- DIETARY_SUPPLEMENT
-
No High phenolic EVOO intake
Medical record of each patient's was followed during 6 month before dietary the intervention
Sponsors & Collaborators
-
National and Kapodistrian University of Athens
collaborator OTHER -
Harokopio University
collaborator OTHER -
University of Peloponnese
lead OTHER
Principal Investigators
-
Prokopios Magiatis, PhD · National and Kapodistrian University of Athens
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 54 Years
- Max Age
- 84 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-15
- Primary Completion
- 2019-06-05
- Completion
- 2019-12-05
Countries
- Greece
Study Locations
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